EARLY Antibiotics aDAptation in Severe Pneumonia(The EARLY ADAPT Study)

University Hospitals (UH)

Status: Not yet enrolling

Conditions: Antibiotic Prescribing for Acute Respiratory-tract Infections; Antibiotic; Intensive Care (ICU); Antibiotic Stewardship; VAP - Ventilator Associated Pneumonia

Treatments: Device: PCR multiplex BioFire Pneumonia plus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07267624

BASEC N° 2024-00369

Details and patient eligibility

About

The objective of the study is to determine whether rapid multiplex PCR testing of respiratory samples can reduce exposure to broad-spectrum antibiotics in intensive care unit patients with suspected or confirmed ventilator-associated pneumonia, compared to standard diagnostic methods.

As secondary objectives, the investigators will study antibiotic management and overall antibiotic consumption, as well as escalation or de-escalation events. The investigators will study the potential clinical impact of using multiplex PCR to see if the length of stay in the intensive care unit is reduced, as well as the duration of mechanical ventilation.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (≥ 18 years old)
• Hospitalized in intensive care with invasive mechanical ventilation ≥ 48 hours
• Administration of antimicrobial therapy for suspected VAP at the time of inclusion.
• Expected survival > 96 hours.

Exclusion criteria

• Enrollment prior to the current trial
• Participation in an interventional study on the management of AMR that has a direct impact on antibiotic therapy practices.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Control Group

No Intervention group

Description:

Care in the control group is based on international guidelines for the management of VAP and carried out in accordance with the local guidelines of each center. This includes respiratory samples with traditional cultures to identify pathogens associated with VAP.

Intervention Group

Experimental group

Description:

In the intervention arm, in addition to traditional cultures for identifying pathogens and their resistance, multiplex PCR will be performed on the patient's respiratory samples. Empirical antibiotic therapy will be directly adapted to the results of multiplex PCR according to the guidelines provided.

Treatment:

Device: PCR multiplex BioFire Pneumonia plus